Medical devices are an integral and indispensable component of patient care. However, they present a number of unique problems that have not been adequately addressed by device manufacturers or the medical community in general. There is ample evidence that errors in the understanding and use of medical devices are responsible for considerable morbidity and mortality. Government agencies have begun to look more closely at the ability of medical institutions as well as manufacturers to accurately assess the dangers presented by medical devices. Further, the FDA has mandated the use of “human factors” experts in the design of medical devices to reduce the complexity of the device/human interface.
Learning to use various medical devices is often taught through textbooks, manuals, lectures, and videotapes. Obviously, while providing a low cost source for learning theory, these informational resources clearly lack the important benefit that can only be acquired from “hands-on” training and practice with the actual device. A number of manufacturers in other industries have designed interactive training systems (software based) to help users learn their specific systems, especially in the flight industry (e.g., Microsoft Flight Simulator™). For example, a manufacturer may include a video, computer program, or interactive web site to illustrate and present step by step instructions on the proper use. A software program with a simulated image of the device controls may also allow a user to practice using a specific device (e.g., U.S. Pat. No. 6,024,539 which discloses a computer image of an infusion pump with various programs for simulating operation of the manufacturer's pump). Each of these training systems are designed solely for the specific instrument being taught.
In order to teach the use of multiple instruments, especially in the medical arena, there are presently available patient simulator mannequins to provide “hands-on” training to medical personnel in areas such as trauma treatment and anesthesiology. These mannequins typically have significant capabilities including spontaneous breathing, pulse, heart and breath sounds and the ability to monitor vital signs such as ECG, pulse oximetry and end-tidal carbon dioxide by connecting commercial off-the-shelf (COTS) medical devices to the simulator. Various medical devices can be attached to these mannequins to train users in the proper implementation and use (e.g., endotracheal tube, EKG monitor, blood pressure cuff, pulse oximeter, automatic external defibrillator). These mannequins are typically computer controlled and are programmed for a variety of responses which simulate medical conditions. Examples of such mannequins are disclosed in U.S. Pat. No. 5,941,710, U.S. Pat. No. 5,900,923, U.S. Pat. No. 5,403,192, and in U.S. Pat. No. 3,520,071, the disclosures of which are incorporated herein by reference.
Using patient simulator mannequins, the students, nurses, medical personnel, etc. can develop skills in manual dexterity and proper placement of leads, tubes, etc. without risk. One unique approach to the use of patient mannequins was taken in U.S. Pat. No. 5,853,292 which discloses using sensor-equipped “virtual” instruments interfaced with a patient simulator through a computer interface module (CIM). The CIM confirms correct placement of the various instruments onto the patient. The system is used in conjunction with a training program on a computer. For example, a user can select the CPR training session. The screen displays include sequential actions which integrate the basic concepts of CPR. The session may be recorded and the results displayed. This system, however, carries over the same disadvantage of the above-noted patient simulators in that it still requires a large capital outlay for the equipment and uses only virtual (rather than real) medical devices. U.S. Pat. No. 6,535,714 relates to medical device training, and, more particularly, to a method, system, and apparatus for training users in the understanding and use of numerous medical devices, including providing for documentation of competency during the training exercise
Further, SimMan™ is a portable and advanced patient simulator for team training from Laerdal Medical. The SimMan™ patient simulator has realistic anatomy and clinical functionality and provides simulation-based education intended to challenge and test students' clinical and decision-making skills during realistic patient care scenarios. The SimMan™ patient simulator provides an interactive manikin allowing learners to practice the emergency treatment of patients
Patient simulators comprise several core elements. The most visible is the patient mannequin, which resembles the mannequins used for cardiopulmonary resuscitation training, although much more advanced. For instance, patient mannequins used for simulation purposes produce breathing sounds as the electro-mechanical lungs inhale and exhale according to computer-based instructions. They have anatomically correct airways as well as a palpable pulse and heart rhythm that can be monitored on an electrocardiograph. Some mannequins have arms and legs that are capable of moving and swelling, and computer-controlled eyes that respond appropriately to various stimuli. Some even have gas analyzers that recognize the makeup of inhaled medications and cause the mannequin to respond accordingly.
The Eagle Patient Simulator, developed by David Gaba, Md., and others, at Stanford University, and marketed by MedSim (Ft. Lauderdale, Fla.), connects to an interface cart that drives the mannequin's electromechanical functions. The cart also serves as the interface for conventional monitoring equipment found in the operating room. For example, it provides a flow of physiological data to off-the-shelf pulse oximeters and invasive blood pressure monitors, further heightening the realism of the simulation. This Stanford simulator has a “split brain,” which consists of two computers that operate simultaneously to control all aspects of the simulation. One computer runs programs designed to simulate the human body, including its cardiovascular, pulmonary, metabolic, fluid and electrolyte balance, and thermal-regulation characteristics. The computer program's sophistication makes it capable of accurately modeling the body's reaction to myriad physiological inputs, such as intravenous drug administration.
The G. S. Beckwith Gilbert and Katharine S. Gilbert Medical Education Program in Medical Simulation is a resource for all Harvard Medical School students and faculty. The Gilbert Program bridges basic and clinical science in an integrated learning lab. Each lab is equipped with a realistic mannequin patient simulator, a seminar table with whiteboard, and a web-connected plasma display. This unified learning lab brings together traditional teaching and web-based information technology all at the bedside of a simulated patient. The mission of the G. S. Beckwith Gilbert and Katharine S. Gilbert Medical Education Program is to “bring to life” good teaching cases for medical students of all levels using high-fidelity patient simulation to foster experiential learning in a safe environment”
The realism of the patient simulators represents only half of the battle regarding the entire educational experience. It is common for the simulation events to be monitored and even recorded, typically on videotape, for peer or teacher review. This critical review and feedback of a session is as important a teaching tool as the simulation itself. In such analysis and feedback, the trainees can have mistakes pointed out and corrected. Conventionally this entails that the entire event is recorded on a camera for playback. The recording of the event is particularly useful in simulations where there are multiple participants, i.e. a “team” of participants, that may have overlapping spheres of influence, and the event recording is the only effective review of the team interaction to review how the team worked together. The simulator itself will often have a recording of the changes in all of the particular simulated physiologic parameters of the simulator (i.e. the data output) over the time of the session for latter analysis, whereby there is an objective review of the session on the simulator (i.e. how did the simulated patient do throughout the event). The data output record of a session does not provide adequate information as to why a particular patient result was achieved in a session, particularly in a team participant environment with overlapping areas of influence relative to the simulated physiologic parameters of the simulator. A video and an audio recording of the event does add the ability to review why a particular result was or was not achieved in a session with the patient simulator. However, there is currently no system for effectively synchronizing these recordings for analysis and for playback (feedback).
In 2003, the Peter M. Winter Institute for Simulation, Education and Research (WISER), which is a large simulation center located at the University of Pittsburgh Medical Center (UPMC), attempted to utilize the Laerdal SimMan™ Simulator to generate Extensible Markup Language (XML) performance logs of simulation sessions that could then be utilized to correlate with a digital primary video file. These log files included events and comments. The digital video recording was stored on a central server with playback made available over the Internet via a standard web browser. Playback was indexed to specific time points during the recording based upon the log files. The time stamp on the performance log was attempted to be utilized as an index mechanism for the primary video file. The system never proved to be effective in practice, however, even the proposed integration was not sufficient to be a meaningful tool for students. The proposed system did not offer independent control over various inputs.
Thus, there is a need in the art to develop method and apparatus for the integrated recording and playback of video, audio and data inputs using training simulators, particularly for patient simulators.